Evive Biotech

The US first-approver advantage over the European Union remains stark, with eight of ten novel agents first cleared by the US Food and Drug Administration, according to a Pink Sheet analysis of rece

The US Food and Drug Administration beats the European Medicines Agency to approval of novel agents across the board, but the imbalance is even more stark in oncology, the largest therapy area, a Pin

The US FDA’s approval of BeiGene, Ltd. ’s PD-1 inhibitor Tevimbra (tislelizumab-jsgr) removes one of the last novel agent applications delayed by COVID-19 from the agency’s review queue. The 13 March

Minoryx Therapeutics /Neuraxpharm Group, Apellis Pharmaceuticals and PTC Therapeutics have all faced setbacks this week following the latest meeting of the European Medicines Agency’s human medici